Skip to content

SIGN UP TO RECEIVE IMPORTANT UPDATES ABOUT IGALMI AND INFORMATION FROM BIOXCEL THERAPEUTICS, INC.

It's our goal to help improve the management of acute agitation associated with schizophrenia or bipolar I or II disorder by providing you and your staff with the latest resources for IGALMI. Sign up now!

*All fields are required unless noted otherwise.

I confirm I am at least 18 years old. I agree that BioXcel Therapeutics, Inc., or companies acting on its behalf, may send me marketing communications (including but not limited to email, fax, telephone (including automatic dialing) or SMS/text (message rates may apply) about BioXcel, its products, services, research, and other information that may be of interest to me. BioXcel will not sell your personal data or transfer it to any unrelated third party for any other purpose without your express consent. I understand that my consent is not required as a condition of purchasing or receiving any goods or services from BioXcel. I understand that BioXcel and companies acting on its behalf will only use my personal data as described in the BioXcel Privacy Policy. I also understand I may opt out of receiving information from BioXcel within future communications.

IMPORTANT SAFETY INFORMATION

INDICATION

See More

Expand button

Collapse

Collapse button

IMPORTANT SAFETY INFORMATION

IGALMI is self-administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope.

WARNINGS AND PRECAUTIONS

Hypotension, Orthostatic Hypotension, and Bradycardia: IGALMI causes dose-dependent hypotension, orthostatic hypotension, and bradycardia. In clinical studies with IGALMI, patients were excluded if they had treatment with alpha-1 noradrenergic blockers, benzodiazepines, other hypnotics or antipsychotic drugs four hours prior to study drug administration; had a history of syncope or syncopal attacks; SBP < 110 mmHg; DBP < 70 mmHg; HR < 55 beats per minute; or had evidence of hypovolemia or orthostatic hypotension. Because IGALMI decreases sympathetic nervous system activity, hypotension and/or bradycardia may be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in geriatric patients. Avoid use of IGALMI in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope. After IGALMI administration, patients should be adequately hydrated and should sit or lie down until vital signs are within normal range. If a patient is unable to remain seated or lying down, precautions should be taken to reduce the risk of falls. Ensure that a patient is alert and not experiencing orthostatic hypotension or symptomatic hypotension prior to allowing them to resume ambulation.

IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Limitations of Use: The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose.

QT Interval Prolongation: IGALMI prolongs the QT interval. Avoid use of IGALMI in patients at risk of torsades de pointes or sudden death, including those with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia, and in patients receiving other drugs known to prolong the QT interval.

Somnolence: IGALMI can cause somnolence. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery, for at least eight hours after taking IGALMI.

Risk of Withdrawal Reactions, Tolerance, and Tachyphylaxis: IGALMI was not studied for longer than 24 hours after the first dose. There may be a risk of physical dependence, a withdrawal syndrome, tolerance, and/or tachyphylaxis if IGALMI is used in a manner other than indicated.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, oral paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.

DRUG INTERACTIONS

Drugs That Prolong the QT Interval: Avoid use. Concomitant use of drugs that prolong the QT interval may add to the QT-prolonging effects of IGALMI and increase the risk of cardiac arrhythmia.

Anesthetics, Sedatives, Hypnotics, and Opioids: Concomitant use may cause enhanced CNS-depressant effects. Reduction in dosage of IGALMI or the concomitant medication should be considered.

USE IN SPECIFIC POPULATIONS

Hepatic Impairment and Geriatric Patients (≥65 years old): A lower dose is recommended in patients with hepatic impairment and geriatric patients. See the full Prescribing Information for the recommended dosage depending on the agitation severity.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact BioXcel Therapeutics, Inc. at 1-833-201-1088 1-833-201-1088 or medinfo@bioxceltherapeutics.com, or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.